(1) Field of the Invention
This invention relates to aqueous soluble precipitates that can stimulate or transfer cell-mediated immunity and to the production thereof from unfractionated bovine transfer factor.
(2) Description of the Prior Art
The prior art teaches that it is not possible to transfer cell-mediated immunity (delayed skin hypersensitivity reaction) with serum. However, viable lymphocytes taken from a reactive person and transferred to a non reactive person will temporarily make the recipient reactive, that is, tuberculin-positive. In man--but not in animals--it is also possible to transfer reactivity of "delayed" reactivity by means of nonviable extracts from lymphocytes. This means, this material, has been referred to as "transfer factor". See Lawrence, H. S. J. Clin. Invest, 219, 34 (1955) and Lawrence H. S. in "Transfer Factor: Basic Properties and Clinical Applications", p. 741 (Ascher, Gottlieb, and Kirkpatrick editors), Academic Press, New York, 1976.
In the prior art Phillip H. Klesius, et al., in Transplanation Proc. VII(3), 449-452, 1975, disclosed the first isolation of transfer factor from cattle lymphocytes. The bovine transfer factor in crude form, stimulated or transferred cell-mediated immunity across species barriers.
The literature discloses that unfractionated bovine transfer factor stimulates or transfers cell-mediated immunity against certain diseases in animals. The efficiency of the unfractionated bovine transfer factor was limited. [See "Bovine Transfer Factor, Isolation and Characteristics" by Phillip H. Kleusius, et al., in "Transfer factor: Basic Properties and Clinical Applications," p. 311 (Ascher, Gottlieb, and Kirkpatrick Editors) Adacemic Press, New York, 1976.]
The teachings of the prior art characterized bovine transfer factor as having properties and characteristics similar to that of human transfer factor. The disadvantage of human material obtained from a single donor in comparison to larger yields obtained from single donor cow. See Klesius, P. H., et al., Clinical Immunology and Immunopathology, 7, p. 240-252, 1977.
There is no known commercial method for the solvent extraction of bovine transfer factor to produce active precipitates with all the characteristics of the present invention. The prior art teaches that liquid chromatography and electrophoresis have yielded small amounts of transfer factor which makes these methods impractical to use as a means of commercial extraction.
The Review of Medical Microbiology, 11th edition, compiled by Drs. Ernest Jawetz, Joseph L. Melnick, and Edward A. Adelberg, provides a brief review of the various facets of pertinent data which would enlighten the reader of the present specification.